Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782219
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2021-02-28
Brief Title:
Validity of Turkish Version of PROMIS-29 Measure
Sponsor:
Bahçeşehir University
Organization:
Bahçeşehir University
Study Overview
Official Title:
Reliability and Validity of the Turkish Version of Patient-Reported Outcomes Measurement Information System-29 in Individuals With Musculoskeletal Diseases
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to Acıbadem Maslak Hospital Orthopedics and Traumatology Department Demographic information age education level occupation marital status will be obtained from the patients they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires
The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS physical function depression anxiety fatigue sleep disorder participation in social activities and pain interaction and 1 question from the intensity of pain Each item has 5 answer options from 1 to 5 only pain intensity has 11 answer options from 0 to 10 From the sum of the answers to each question in the domain the total raw score for each domain is calculated resulting in seven domain scores each between 4 and 20 SF-36 is the most widely used scale to assess general health status and 36 items question 8 content physical function physical role pain general health social function energy fitness social function emotional role mental health The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2
The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research
Participants will first be asked to sign the informed consent form electronically PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform
The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2 a similar general health profile questionnaire
To evaluate inter-rater test-retest reliability both scales will be filled in by patients a second time between 7-14 days
The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS physical function depression anxiety fatigue sleep disorder participation in social activities and pain interaction and 1 question from the intensity of pain Each item has 5 answer options from 1 to 5 only pain intensity has 11 answer options from 0 to 10 From the sum of the answers to each question in the domain the total raw score for each domain is calculated resulting in seven domain scores each between 4 and 20 SF-36 is the most widely used scale to assess general health status and 36 items question 8 content physical function physical role pain general health social function energy fitness social function emotional role mental health The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2
The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research
Participants will first be asked to sign the informed consent form electronically PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform
The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2 a similar general health profile questionnaire
To evaluate inter-rater test-retest reliability both scales will be filled in by patients a second time between 7-14 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None